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Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05465850
Collaborator
(none)
60
Enrollment
3
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of the study is to clinically evaluate the shade matching and clinical performance of the Universal shade composites Omnichroma and GC Essentia versus the multi shade composite Filtek Z350XT in restoring cervical lesions of anterior teeth.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Modified USPHS criteria
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth ( Randomized Clinical Trial ) - 1 Year Follow up
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Filtek Z350XT

Diagnostic Test: Modified USPHS criteria
It assess the restorations with visual inspection using a mirror and explorer. It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries.
Experimental: Essentia universal shade, GC composite

Diagnostic Test: Modified USPHS criteria
It assess the restorations with visual inspection using a mirror and explorer. It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries.
Experimental: Omnichroma composite

Diagnostic Test: Modified USPHS criteria
It assess the restorations with visual inspection using a mirror and explorer. It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries.

Outcome Measures

Primary Outcome Measures

  1. Clinical performance (USPHS criteria) [baseline: 1 week]

    USPHS criteria

  2. Clinical performance (USPHS criteria) [6 months]

    USPHS criteria

  3. Clinical performance (USPHS criteria) [12 months]

    USPHS criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Class V carious lesions in anterior teeth

  • Vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis.

  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion Criteria:

  • Deep carious defects ( Close to pulp, less than 1 mm distance)

  • Periapical pathology or signs of pulpal pathology

  • Endodontically treated teeth

  • Tooth hypersensitivity

  • Possible prosthodontic restoration of teeth

  • Heavy occlusion and occlusal contacts or history of bruxism

  • Severe periodontal affection

  • Lesions in premolars and molars

  • Posterior teeth

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dina Khaled Mokhtar Mohamed, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05465850
Other Study ID Numbers:
  • 14422019428237
First Posted:
Jul 20, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dental Caries

Study Results

No Results Posted as of Jul 20, 2022